jaw print

3D medical and bio-printing. Get ready, this technology is no longer the future.

Posted on November 19, 2014 · Posted in Medical Device Trends

Over the last 10 years the 3D printing industry has changed dramatically. As materials and printing technologies have advanced, the shift into printing products for the human body has made exponential advances. We are seeing advances in medical device implants, tissue printing and the printing of 3D models to aid surgeons with complicated surgeries.

However, aside from the medical and health advantages, be prepared to navigate a somewhat “cloudy” regulatory landscape.

Advances in the medical device industry:

  • In the last year alone, the FDA approved the first 3D printed cranial implant. This cranial implant is made of a specialized polymer designed by Oxford Performance Materials: OsteoFab. The material has a similar density to corticol bone which better integrates with the body’s existing bone structures. By combining this specialized material with the technology of 3D scanning and printing, a customized, and intricate part can be printed for patients suffering from skull injuries or facial trauma.
  • 4Web Medical, located in Frisco, Texas may be the first company to receive FDA clearance for their 3D printed, metal spinal Implant. As of Q3, 2014 the company has implanted over 3000 units in various patients across the United States. Their patented truss design is showing strong progress in the market.

    What are the FDA regulatory challenges and expectations for printed devices?

  • The FDA completed an Additive Manufacturing, public workshop in October 2014. Major manufacturers, researchers and industry professionals attended to meeting to discuss the future of the industry and offer suggestions for updated FDA guidance. We may see additive manufacturing regulations/compliance standards designed in a similar fashion to the process controls already used for mass manufactured medical devices. Expect new guidance documents to be drafted by the FDA in the coming year.
  • ASTM has also issued guidance around metal powder properties that can be used for additive manufacturing.
    You can see more here: ASTM-F3049-14 Standard.

  • Advances in the Bio-printing industry:

  • A company by the name of TeVido has developed a working process for printing breast tissue to be used in reconstructive surgery or lumpectomy’s performed on cancer patients. Watch a YouTube video here. TeVido’s tissue printing technology is also being researched for use on burn wounds and other traumatic injuries to human tissue.
  • 3D Bioprinting Solutions, located in Russia at the Skolokova Innovation Center, is developing breakthrough printing technology of human tissue.

    “The lab’s global mission is to find solutions for a huge swathe of people who need to repair compromised organs or require transplant in the event of organ failure,” said Vladimir Mironov, the laboratory’s director of science. As the Skolkovo website reports, the Russian built bioprinter – which adds to a global line up currently comprising 14 different models – works by distributing so-called tissue spheroids, or bio-ink, in successive layers in a kind of scaffold structure made of hydrogel. The gel is then washed away, leaving behind three-dimensional tissue that matches a computer design down to the individual cell.”

    What are the FDA regulatory challenges and expectations for bioprinting?

    We may be 10 years off from final, FDA regulatory guidance in the bio-printing (and even drug printing) areas. Regardless, this technology should be watched closely. Research and development is moving forward and global military units are very interested in seeing advancement in this technology.

    3D printing in the medical industry can no longer be ignored. Pediatric, plastic and cardiac surgeons are working with 3D printing labs to print scanned images of damaged or defective human organs. These printed models allow surgeons to view damage that could not be detected in 2D images. This technology is giving surgeons a customized road-map for complicated surgeries.

    Could it be, we are truly facing the reality of “bionic” organs and body parts? It will be exciting to watch this innovative technology expand over the next few years.

    Image courtesy of http://www.telegraph.co.uk: “3D printer builds new jaw bone” by Shane Richmond, Feb. 2012